Hyloris P-004 Project (NDA) – Inherited bleeding disorders

HYLORIS P-004 Project

dreamstimelarge_61070246HYL-P-004 is an oral rinse solution to treat patients with hemophilia for short-term use to prevent or reduce hemorrhage, and reduce the need for replacement therapy, during and following surgical and non-surgical dental procedures.

HYL-P-004 oral rinse solution facilitates the use of antifibrinolytic therapy in dental patients and minimizes systemic exposure from the administration of the injection form and reduces the need of factor replacement therapy which may lead to the development of inhibitors and antibodies, increasing the risk of mortality of hemophilia patients.


Hemophilia is an inherited bleeding disorder characterized by a lifelong defect in the clotting mechanism. Hemophilia A and B are characterized by a deficiency of factor VIII and IX respectively (both inherited as X linked recessive).

Hemophilia and oral dental care

The provision of dental treatment in patients with congenital bleeding disorders must not be neglected. The main option available to control bleeding during primary dental care is factor replacement therapy (FRT). Even if the development of recombinant FRT has minimized the risk of blood borne infections, the major disadvantage reported is the development of antibodies or inhibitors to FRT, which could expose the patients to serious bleeding, increasing the risk of mortality of hemophilia patients.

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